Drugs@FDA: FDA-Approved Drugs
Company: ICU MEDICAL INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | SODIUM CHLORIDE | 900MG/100ML | INJECTABLE;INJECTION | Prescription | AP | Yes | Yes |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 02/24/1972 | ORIG-1 | Approval | Type 5 - New Formulation or New Manufacturer | STANDARD |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 04/27/2016 | SUPPL-215 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/21/2017 | SUPPL-214 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/016366s214lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/016366Orig1s214ltr.pdf | |
| 09/08/2014 | SUPPL-212 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/17/2014 | SUPPL-201 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/16/2007 | SUPPL-174 | Labeling |
Label is not available on this site. |
||
| 04/10/2006 | SUPPL-167 | Labeling |
Label is not available on this site. |
||
| 11/01/2002 | SUPPL-161 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 05/03/2000 | SUPPL-160 | Labeling |
Label is not available on this site. |
||
| 05/03/2000 | SUPPL-159 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 12/01/1998 | SUPPL-157 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/21/1997 | SUPPL-156 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/20/1997 | SUPPL-155 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/11/1997 | SUPPL-154 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/25/1999 | SUPPL-153 | Labeling |
Label is not available on this site. |
||
| 03/28/1997 | SUPPL-152 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/06/1996 | SUPPL-151 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/04/1996 | SUPPL-150 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/29/1996 | SUPPL-149 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/29/1996 | SUPPL-148 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/14/1995 | SUPPL-146 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/24/1994 | SUPPL-145 | Labeling |
Label is not available on this site. |
||
| 08/30/1991 | SUPPL-142 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/28/1992 | SUPPL-141 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/10/1991 | SUPPL-140 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/11/1990 | SUPPL-138 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/22/1990 | SUPPL-137 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/14/1989 | SUPPL-136 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/17/1988 | SUPPL-135 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/07/1988 | SUPPL-134 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/30/1987 | SUPPL-131 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/26/1986 | SUPPL-130 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/24/1986 | SUPPL-129 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/18/1986 | SUPPL-128 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/22/1986 | SUPPL-127 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/21/1985 | SUPPL-124 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/10/1985 | SUPPL-123 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/07/1985 | SUPPL-122 | Labeling |
Label is not available on this site. |
||
| 01/31/1986 | SUPPL-120 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/27/1985 | SUPPL-119 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/26/1985 | SUPPL-114 | Labeling |
Label is not available on this site. |
||
| 05/03/1985 | SUPPL-111 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/26/1985 | SUPPL-110 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/18/1985 | SUPPL-109 | Labeling |
Label is not available on this site. |
||
| 01/18/1985 | SUPPL-108 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/22/1984 | SUPPL-105 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/26/1985 | SUPPL-104 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/23/1985 | SUPPL-102 | Labeling |
Label is not available on this site. |
||
| 04/23/1985 | SUPPL-101 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/29/1985 | SUPPL-100 | Labeling |
Label is not available on this site. |
||
| 11/29/1985 | SUPPL-99 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/29/1985 | SUPPL-98 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/25/1986 | SUPPL-97 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/06/1986 | SUPPL-96 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/08/1985 | SUPPL-95 | Labeling |
Label is not available on this site. |
||
| 01/08/1985 | SUPPL-94 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/09/1984 | SUPPL-93 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/14/1984 | SUPPL-92 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/25/1984 | SUPPL-91 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/17/1984 | SUPPL-90 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/21/1984 | SUPPL-89 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/31/1983 | SUPPL-88 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/17/1983 | SUPPL-87 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/08/1983 | SUPPL-86 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/19/1983 | SUPPL-85 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/06/1983 | SUPPL-84 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/25/1983 | SUPPL-83 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/10/1984 | SUPPL-82 | Labeling |
Label is not available on this site. |
||
| 10/10/1984 | SUPPL-81 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/26/1982 | SUPPL-80 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/01/1984 | SUPPL-79 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/15/1983 | SUPPL-78 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/26/1982 | SUPPL-77 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/22/1982 | SUPPL-76 | Labeling |
Label is not available on this site. |
||
| 02/01/1982 | SUPPL-75 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/08/1982 | SUPPL-74 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/09/1982 | SUPPL-73 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/25/1981 | SUPPL-72 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/21/1981 | SUPPL-71 | Labeling |
Label is not available on this site. |
||
| 10/21/1981 | SUPPL-70 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/16/1981 | SUPPL-69 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/31/1981 | SUPPL-68 | Labeling |
Label is not available on this site. |
||
| 07/31/1981 | SUPPL-67 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/02/1981 | SUPPL-66 | Labeling |
Label is not available on this site. |
||
| 08/31/1982 | SUPPL-65 | Labeling |
Label is not available on this site. |
||
| 03/02/1981 | SUPPL-64 | Labeling |
Label is not available on this site. |
||
| 03/02/1981 | SUPPL-63 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/07/1981 | SUPPL-62 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/15/1980 | SUPPL-61 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/16/1981 | SUPPL-59 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/10/1980 | SUPPL-58 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/28/1980 | SUPPL-57 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/12/1980 | SUPPL-56 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/08/1980 | SUPPL-55 | Labeling |
Label is not available on this site. |
||
| 10/10/1979 | SUPPL-54 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/29/1979 | SUPPL-53 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/21/1980 | SUPPL-52 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/16/1980 | SUPPL-51 | Labeling |
Label is not available on this site. |
||
| 04/16/1980 | SUPPL-50 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/27/1979 | SUPPL-49 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/03/1979 | SUPPL-48 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/03/1979 | SUPPL-47 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/17/1979 | SUPPL-46 | Labeling |
Label is not available on this site. |
||
| 01/05/1979 | SUPPL-45 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/01/1979 | SUPPL-44 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/16/1979 | SUPPL-43 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/25/1978 | SUPPL-42 | Labeling |
Label is not available on this site. |
||
| 10/25/1978 | SUPPL-41 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/27/1979 | SUPPL-40 | Labeling |
Label is not available on this site. |
||
| 03/27/1979 | SUPPL-39 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/08/1978 | SUPPL-38 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/27/1978 | SUPPL-37 | Labeling |
Label is not available on this site. |
||
| 10/27/1978 | SUPPL-36 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/20/1978 | SUPPL-35 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/27/1979 | SUPPL-34 | Labeling |
Label is not available on this site. |
||
| 03/27/1979 | SUPPL-33 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/06/1979 | SUPPL-32 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/03/1978 | SUPPL-31 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/15/1978 | SUPPL-30 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/08/1978 | SUPPL-29 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/26/1978 | SUPPL-27 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/06/1978 | SUPPL-26 | Labeling |
Label is not available on this site. |
||
| 02/08/1978 | SUPPL-25 | Labeling |
Label is not available on this site. |
||
| 06/02/1978 | SUPPL-24 | Labeling |
Label is not available on this site. |
||
| 06/02/1978 | SUPPL-23 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/05/1978 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/31/1978 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/13/1978 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/28/1977 | SUPPL-17 | Labeling |
Label is not available on this site. |
||
| 03/15/1978 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/23/1978 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/15/1977 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/15/1977 | SUPPL-13 | Labeling |
Label is not available on this site. |
||
| 06/08/1978 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/29/1977 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/08/1976 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/20/1975 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/03/1975 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/29/1975 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/19/1975 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/07/1975 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/19/1975 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
| 03/02/1976 | SUPPL-1 | Labeling |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 09/21/2017 | SUPPL-214 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/016366s214lbl.pdf |
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
INJECTABLE;INJECTION; 900MG/100ML
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | SODIUM CHLORIDE | 900MG/100ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 017464 | B BRAUN |
| SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | SODIUM CHLORIDE | 900MG/100ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 019635 | B BRAUN |
| SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | SODIUM CHLORIDE | 900MG/100ML | INJECTABLE;INJECTION | Prescription | No | AP | 207310 | FRESENIUS KABI USA |
| SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | SODIUM CHLORIDE | 900MG/100ML | INJECTABLE;INJECTION | Prescription | No | AP | 078177 | FRESENIUS MEDCL |
| SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | SODIUM CHLORIDE | 900MG/100ML | INJECTABLE;INJECTION | Prescription | No | AP | 076316 | HAEMONETICS |
| SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | SODIUM CHLORIDE | 900MG/100ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 019480 | HOSPIRA |
| SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | SODIUM CHLORIDE | 900MG/100ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 016366 | ICU MEDICAL INC |
| SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | SODIUM CHLORIDE | 900MG/100ML | INJECTABLE;INJECTION | Prescription | No | AP | 207956 | LABORATORIOS GRIFOLS |